Preloaded sterile bag

ABSTRACT

A sterile bag for covering medical equipment comprises: a barrier section, a flexible body section, and an attaching section. The flexible body section has a tubular shape extending from a proximal end to a distal end thereof, and an outer surface, an inner surface, and an open end. The barrier section is coupled to the proximal end, and the attaching section is formed at the distal end of the flexible body section. The barrier section is a rigid or semirigid component which attaches the sterile bag to a sterile component or to an unsterile component of the medical equipment in a pleaded or folded state. The flexible body section is configured to be deployed over the unsterile component so as to enclose within the inner surface thereof the unsterile component. The unsterile component is connectable to the sterile component through the central opening of the barrier section.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. provisional application62/840,932, filed Apr. 30, 2019, the disclosure of which is incorporatedby reference herein in its entirety.

BACKGROUND INFORMATION Field of the Disclosure

The present disclosure relates to medical devices. More particularly,the disclosure exemplifies a sterile bag preloaded onto a sterilemedical device and methods of deploying and using the same duringinteraction of sterile and unsterile medical devices.

Description of Related Art

Sterilization refers to any process that effectively renders anysurface, equipment or article free from viable microorganisms. Sterilityand its maintenance, together with the prevention of cross-infection,are at the top of any list of critical factors in patient care. Inpractice, however, it is impossible to prove that all organisms havebeen destroyed. Therefore Sterility Assurance levels (SAL) are used as ameasure of the survival level of microorganisms after terminalsterilization. In Europe, for example, items such as medical devices canonly be labelled “sterile” if the chance of an item remainingcontaminated after sterilization is less than or equal to one chance ina million. Therefore, the packaging around medical devices is carefullydesigned so that it allows those devices to be sterilized, provides amicrobial barrier and maintains sterility effectively up to the point ofuse. This type of packaging is known as a sterile barrier system. Asterile barrier system is an essential part of a sterile medical device.

In the medical field, for devices requiring an unsterile and sterilecomponent to interface with each other and pass together into a sterilefield, the prior state of the art has primarily relied on a removablesterile cover (e.g., a drape or a bag) that acts as a barrier whendeployed over the unsterile component(s). This type of removable cover,in the form of a sterile drape, blanket, or bag, is often rolled orpleated prior to being deployed over the unsterile components tominimize the chance of loss of sterility. To facilitate deployment, tabsare included on the deployment end of the barrier for the user to gripwhile deploying the barrier. To facilitate attachment, an attachedcomponent with a good degree of rigidity or another attachment mechanismmay anchor the barrier to the component(s) which the barrier covers.Examples of patent publications related to this type of removablesterile barrier deployable over unsterile components include U.S. Pat.No. 8,459,266 B2 entitled “Pleated bag for interventional pullbacksystems” and pre-grant patent application publication US 20140338676 A1entitled “Medical drape and methods of covering equipment with medicaldrapes”. Additional examples of sterile covers are disclosed inpre-grant patent application publications US 20170333147 A1, US20160361129 A1, and US 20170258544 A1.

For medical systems with the need to cover unsterile components with asterile bag or drape that interface with sterile components and passinto a sterile field, the bag or drape does not come preloaded to thesterile component. Hence, the use o such barrier requires the user toload a sterile barrier to the sterile/unsterile interface, deploy thebag or drape over the unsterile components, and then load or connect thesterile disposable components to the already covered non-sterilecomponents. This process is time consuming and is prone to accidentalloss of sterility when a sterile component comes into contact with anunsterile user or component.

Additionally, in the event that the sterile barrier comes into contactunsterile components, current state of the art lacks the ability toreplace a sterile barrier without removing the single-use, sterile,disposable components from the interface. If a mechanism exists toprevent the reuse/reattachment of the sterile components after removaland replacement of the barrier despite the maintenance of sterility ofthe disposable components, then removal and replacement of the barrieralso requires removal and replacement of the disposable sterilecomponent.

Furthermore, current state of the art requires removal of a sterilebarrier should the disposable, sterile components need to be removedand/or replaced after barrier deployment, further adding cost and userburden. Moreover, current sterile barrier/drapes lack a method forsecuring the barrier orifice on the unsterile end so as to prevent thesterile exterior surface of the barrier from coming into contact withunsterile surfaces before passing into the sterile field, henceincreasing the likelihood of compromising the sterility of the sterilebarrier.

It is evident, therefore, that there is a need for improved sterilebarrier/drapes that can provide quick deployment and improved sterility.

SUMMARY OF EXEMPLARY EMBODIMENTS

According to at least one embodiment of the disclosure, there isprovided an apparatus comprising a sterile bag preloaded to a disposablesterile component (e.g., catheter handle) in a rolled or folded state;the preloaded sterile bag is configured to be deployed over an unsterilecomponent, where the deployment process takes place in parallel with theengagement of the sterile and unsterile components (e.g., sterile bagdeployment occurs in parallel with catheter motor engagement). Upondeployment, a distal end of the sterile bag can be affixed with anattachment to the modality's cart to minimize the possibility of contactwith unsterile surfaces or components. The sterile bag can be removablefrom catheter handle to allow for replacement if the unsterile surfaceof the bag is contacted by non-sterile components.

In its simplest form, the present disclosure provides a sterile coverfor covering medical equipment, comprising: a barrier componentconfigured to be coupled to a sterile component of the medicalequipment; and a flexible body coupled to the barrier component, theflexible body having a tubular shape extending from a proximal end to adistal end thereof, and having an outer surface, an inner surface and anopen end, wherein the flexible body is configured to enclose within theinner surface a non-sterile component connectable to the sterilecomponent.

These and other objects, features, and advantages of the presentdisclosure will become apparent upon reading the following detaileddescription of exemplary embodiments of the present disclosure, whentaken in conjunction with the appended drawings, and provided claims.

BRIEF DESCRIPTION OF DRAWINGS

Further objects, features and advantages of the present disclosure willbecome apparent from the following detailed description when taken inconjunction with the accompanying figures showing illustrativeembodiments of the present disclosure.

FIG. 1 shows an exemplary medical imaging system where a sterile coveror bag may be implemented.

FIG. 2 shows an exemplary embodiment of a sterile cover deployed overnon-sterile components of the imaging system.

FIGS. 3A, 3B and 3C show various views of an exemplary sterile cover orbag 1200, according to an embodiment of the present disclosure. FIG. 3Ashows a plane view of a barrier section 1210, FIG. 3B shows a plane viewof an attaching section 1220, and FIG. 3C shows a three-dimensional viewof a flexible body section 1202 coupled to the barrier section 1210 andto the attaching section 1220 of the exemplary sterile cover or bag 1200preloaded onto a sterile component.

FIG. 4A shows an exemplary sterile cover or bag 1200 preloaded onto asterile component, and FIG. 4B shows an exemplary process of deployingthe preloaded sterile cover 1200 over a non-sterile component inparallel with the engagement of the sterile component to non-sterilecomponent.

FIGS. 5A, 5B, 5C, 5D, 5E, and 5F each shows a different design of thebarrier section 1210 of the sterile cover or bag 1200, where the barriersection has an opening configured to engage with a connecting portion1152 of a sterile component.

FIG. 6A illustrates a plane view of an exemplary connecting portion 1152configured to engage with the barrier section 1210 of FIG. 5E, FIG. 6Billustrates a plane view of an exemplary connecting portion 1152configured to engage with the barrier section 1210 of FIG. 5F.

FIG. 7A, FIG. 7B, and FIG. 7C show details of an exemplary sterilecover, drape, or bag 1200 configured to be preloaded to a sterilecomponent or to be attached to an unsterile component of medicalequipment.

Throughout the figures, the same reference numerals and characters,unless otherwise stated, are used to denote like features, elements,components or portions of the illustrated embodiments. Moreover, whilethe subject disclosure will now be described in detail with reference tothe figures, it is done so in connection with the illustrative exemplaryembodiments. It is intended that changes and modifications can be madeto the described exemplary embodiments without departing from the truescope and spirit of the subject disclosure as defined by the appendedclaims.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached”, “coupled” orthe like to another feature or element, it can be directly connected,attached or coupled to the other feature or element or interveningfeatures or elements may be present. In contrast, when a feature orelement is referred to as being “directly connected”, “directlyattached” or “directly coupled” to another feature or element, there areno intervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown in one embodiment can apply to other embodiments. It will alsobe appreciated by those of skill in the art that references to astructure or feature that is disposed “adjacent” to another feature mayhave portions that overlap or underlie the adjacent feature.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The embodiments are based on the object of providing a sterile cover forcovering medical equipment which includes sterile and non-sterilecomponents. The sterile cover includes a barrier component configured tobe coupled to a sterile component of the medical equipment; and aflexible body coupled to the barrier component, the flexible body havinga tubular shape extending from a proximal end to a distal end thereof,and having an outer surface, an inner surface, and an open end. Theflexible body is configured to enclose within the inner surface thereofa non-sterile component connectable to the sterile component.

Many medical devices require a sterilized component capable of extendinginto a sterile field, without risk of contaminating that field, wherethat sterile component interfaces with an unsterile component needed tooperate the device. In this situation, the unsterile component canpotentially enter the sterile field and negate the sterility of thatfiled. A solution to prevent loss of sterility has been to deploy asterile barrier over any unsterile component entering the sterile field.This especially applies to medical devices used in in-vivo environments,where sterile components such as interventional deployment systemcatheters must interface with an electronic controller which cannot besterilized.

Examples of such in-vivo deployable systems include an optical coherencetomography (OCT) catheter system which includes a catheter containing animaging optical component that interfaces with a pullback systemenabling catheter deployment and imaging functionality. The pullbacksystem in turn interfaces with a computer system responsible for thedigital operations of the system.

FIG. 1 shows an exemplary medical imaging system 1100. The medicalimaging system 1100 includes an imaging console 1110 and a mechanicallyrotated optical probe 1120 (e.g., an endoscope or catheter). A patientinterface unit (PIU) 1130 connects the optical probe 1120 to the imagingconsole 1110 using a cable bundle 1106. The imaging console 1110includes, among other things, a computer cart 1102 and one or moredisplays 1104. The optical probe 1120 may include, for example, afiber-optic based catheter 1124 and a catheter handle 1122. The handle1122 has a proximal end and a distal end extending along a z-axisdirection. In an exemplary imaging procedure, the imaging system console1100 controls the catheter 1124 via the PIU 1130 to obtain images of atarget sample (not shown), such as a cardiovascular bodily lumen of apatient.

The PIU 1130 is the main interface between the probe 1120 and the systemconsole 1110. The PIU 1130 provides the means to spin and linearlytranslate the catheter's imaging core within the catheter's stationaryouter sheath (not labeled). The system console 1110 and PIU 1130 areconnected to each other by the cable bundle 1106. The cable bundle 1106houses therein cables for transmitting electrical power and forcommunication signaling, as well as optical fibers for illumination acollection of light. During use of the imaging system console 1100, theentire PIU 1130 is preferably covered with a sterile drape/bag 1200 andplaced on the patient's bed or operating table. The PIU 1130 may providea user interface for operating the imaging functions of the probe froman sterile field by the use of actionable buttons 1131; these buttons1131 may mirror other controls provided on a graphical user interface(GUI) at the imaging console 1110. The state of each button 1131 (e.g.,active, inactive, warning, etc.) is communicated by indicator LEDsprovided on the housing of the PIU; and these indicators too aremirrored on the GUI of display 1104. Therefore, users of the medicalimaging system 1100 may perform the same operations from either anon-sterile field using the GUI in display 1104 or from the sterilefield using the buttons 1131 on the PIU 1130. The PIU 1130 is composedof a beam combiner (not shown), a fiber optic rotary joint (FORJ), amotion mechanism including a rotational motor and a linear stage,electronic control boards, control buttons and/or an LED panel 1131, anda catheter receptacle 1150.

The catheter 1124 and the handle 1122 that the catheter attaches to areintended to be single-use, sterile components. However the PIU 1130 anda pullback unit (included in the PIU, but not shown) that the catheterinterfaces with must be multi-use and unsterile due to costs associatedwith maintaining or rendering its sterility before use or implementingit as single-use component. The PIU 1130 and pullback unit, whenattached to the catheter, must pass into the sterile field in order tofacilitate proper catheter deployment control and repositioning.Therefore, a sterile barrier must be introduced between the PIU 1130with its cable bundle 1106 and the sterile surfaces (e.g., operatingtable) and catheter handle that it touched in order to avoidcontamination of these sterile surfaces.

To that end, the present disclosure provides a novel sterile barrier (asterile bag or sterile cover) 1200 which extends over the unsterilecomponent(s) of a device requiring passage of said unsterile componentsinto a sterile field. Notably, this novel sterile barrier allowsinterfacing with the sterile component(s) of the device, whilesatisfying the need for maintenance of sterility in the sterile fieldduring device deployment and use.

FIG. 2 shows an exemplary embodiment of the sterile bag 1200 deployedover non-sterile components of the imaging system 1100. In FIG. 2, thebag proximal end and bag distal end are shown in the direction ofdeployment. As shown in FIG. 2, a sterile bag 1200 includes a flexiblebody section 1202, a barrier section 1210, and an attaching section1220. The flexible body section 1202 has a tubular shape extending froma proximal end to a distal end thereof, and having an outer surface, aninner surface, and an open end. As used herein, the term “tubular shape”refers to the flexible body section 1202 being any sterile drapingstructure having a hollow opening through the center, forming a tube,which can have many different sizes and shapes. For example, theflexible body section 1202 can have a tubular shape long and narrow insome embodiments, while in other embodiments the flexible body section1202 can have a tubular shape short and wide. Moreover, the term tubularshape does not necessarily limit the flexible body section 1202 to atubular shape having circular cross-section. In the present disclosure,the flexible body section 1202 can have a tubular shape which issubstantially cylindrical, as in the example shown in FIG. 2. In otherembodiments, the tubular shape of the flexible body section 1202 canhave a rectangular cross-section, so as to have a rectangular tubularshape. In further embodiments, the flexible body section 1202 can havean irregular tubular shape, or the flexible body section 1202 can beopen as a flat sheet rolled on one end to form the outer edge of thebarrier section 1210, and the other end (attaching section 1220) tapedonto the surface of computer cart 1102. In FIG. 2, the flexible bodysection 1202 is shown as a tube for ease of illustration, but it is notlimited to just tubular shapes. Indeed, to facilitate manipulating andengagement/disengagement of sterile components to unsterile components,the flexible body section 1202 may take any shape to even conform to theshape of the medical equipment being covered. In terms of material, theflexible body section 1202 may be made of any suitable, flexiblematerial including textile and/or plastic materials typically used forconventional medical drapes.

The barrier section 1210 includes an outer edge 1212 and a passage 1211(central opening or through hole). The attaching section 1220 includesone or more attaching components such as an attaching tab 1221 having athru-hole 1222. In its deployed state, the flexible body section 1202 ofthe sterile bag (or sterile cover) 1200 has a substantially tubularshape configured to enclose therein non-sterile components including, inthe present embodiment, at least the PIU 1130 and cable bundle 1106.

In one embodiment, to reduce the possibility of contact between thesterile bag 1200 and an unsterile surface during or after deployment,the attaching section 1220 may include two or more tabs 1221 each with asmall-diameter thru-hole 1221. Additionally, a small hook 1223 for eachtab 1221 can be installed around the interface between the unsterilecable bundle 1106 and the main body of the computer cart 1102. Thesterile bag 1200, when deployed by an unsterile user, can be held withthe hooks 1223 so as to avoid contact between the sterile surface of thebag and the user. When fully deployed, the tabs 1221 can be affixed tothe hooks 1223 on the main body of computer cart 1102, therebytemporarily holding the barrier in place while the unsterile component(e.g., PIU 1130) is repositioned. Thus, reducing the possibility of theexterior surface of the sterile bag coming into contact with anunsterile surface outside of the sterile field. FIG. 2 shows the fulldevice with the sterile bag 1200 deployed and affixed to the hook 1223,reducing the possibility of contact between barrier section 1210 andunsterile components (PIU 1130, cable bundle 1106).

Conventionally, the process for sterile bag deployment over thenon-sterile components (e.g., PIU 1130, cabling, etc.) is slow becausethe sterile bag is provided as a separate package and it must bedeployed over the PIU before the catheter 1124 is engaged to the PIU. Inthis process, if the sterile bag comes into contact with non-sterilecomponents, surfaces or users, the sterile bag may lose sterility beforeeven passing into sterile field.

According to the present disclosure, a sterile bag is configured to bepreloaded to the disposable catheter handle 1122 in a compact (rolled orpleated) state. In this manner, at the time of deployment process,deployment of the sterile bag can take place at the same time (inparallel) with catheter-to-PIU engagement. To that end, the sterile bag1200 disclosed herein takes advantage of specifically designedcomponents (sections) which allow the sterile bag to stay compactlyattached to the catheter handle prior to deployment and can be quicklydeployed during catheter-to-motor engagement.

FIGS. 3A and 3B show an exemplary embodiment of the attaching section1220 and the barrier section 1210 of the sterile bag 1200. As shown inFIG. 2, the flexible body section 1202 of the sterile bag 1200 has aproximal end and a distal end. At the proximal end, the flexible bodysection 1202 ends with, or is attached to, the barrier section 1210. Atthe distal end, the flexible body section 1202 ends with the attachingsection 1220. FIG. 3A shows an exemplary embodiment of the barriersection 1210 as seen in the direction along the z axis. The barriersection 1210 has or forms an opening 1211 with a diameter D₁ sized tofit a connecting portion 1152 (junction element) of the catheter handle1122. The connecting portion 1152 (junction element) of the catheterhandle 1122 has a diameter “d” approximately the same size of diameterD₁ (d≈D₁). FIG. 3B shows an exemplary embodiment of the attachingsection 1220 also as seen in the direction along the z axis. Theattaching section 1220 includes one or more (two in the embodiment ofFIG. 3B) attaching tabs 1221, each tab with a thru-hole 1222. Theattaching section 1220 in the shape of a ring that has or forms anopening 1225 with a diameter D₂ (larger than D₁) sized to allow passagetherethrough of non-sterile components, such as the PIU 1130 and cablebundle 1106.

Here, a “ring” shaped attaching section 1220 is an optional oralternative embodiment to attach the sterile bag or drape to the system.As noted above with respect to FIG. 2 and mentioned elsewhere in thisdisclosure, it is sufficient that the sterile bag 1200 includes anattaching section 1220 (attaching component) of any shape or structurewhich allows secure attachment of the bag's distal end to a fixedsurface of the system. To that end, any other attachment structure(e.g., adhesives such as Velcro®) can be used to attach the distal endof the sterile bag 1200 to an unsterile surface (e.g., the surface ofthe computer cart 1102). The attaching component may include otherattaching structures, e.g., fasteners, a clasp, buttons, a zipper or anyother suitable mechanism, which can be attached and removed in anysuitable manner.

The attaching section 1220 (attaching component) having a ring shape canbe made of a rigid polymer, such as nylon; it can be cut from a thinsemirigid Mylar sheet, or it can even be made from a piece of sterilizedcardboard, etc. Alternatively, a ring shaped attaching section 1220 maybe just the open end of a sterile plastic bag. For example, in oneembodiment, the simplest implementation of the sterile bag 1200 orsterile cover may be just a long plastic bag with a hole punched in thebottom of the bag through which a connection between the PIU and thecatheter handle is made. In this case, the open end of the plastic bagmay be reinforced with a piece of rigid or semirigid material to form aring shaped component around the edge of the bag, and this reinforcededge can be attached to the computer cart of the system. In a furtheralternative, the open end of a plastic bag can have a hole or more thanone hole punched around the edge of the bag, so that the bag can beattached directly to some structure of the system's computer cart.

FIG. 3C shows (for convenience of illustration) the sterile bag 1200 ina predeployed state, where the flexible body section 1202 of the sterilebag 1200 is rolled or creased or folded or pleated to remain compactprior to deployment.

In FIG. 3C, when the sterile bag 1200 is preloaded onto the proximal endof the catheter handle 1122, the opening 1211 of the barrier section1210 slides over the connecting portion 1152 of the catheter handle 1122while the attaching section 1220 and flexible body section 1202 arepulled in a direction of axis z (towards the distal end of the catheterhandle). The opening 1211 slides over the connecting portion 1152 untilthe barrier section 1210 abuts against a flange 1122 a of the catheterhandle 1122. To maintain sterility of the catheter handle 1122 and thesterile bag 1200, during the preloading process, at least part of theinner surface 1202 a of the flexible body section 1202 is exposedoutwards. Then, after the sterile bag is preloaded onto the catheterhandle 1122, the flexible body section 1202, the barrier section 1210,and the attaching section 1220 are rolled or creased or folded orpleated to remain compact prior to deployment. In other embodiments, thesterile bag 1200 can be deployed onto a non-sterile device without beingpreloaded onto a sterile device.

FIGS. 4A and 4B show an exemplary process of deploying the preloadedsterile bag 1200 over non-sterile components in parallel to catheterengagement to the PIU. According to the present disclosure, preloadingthe sterile bag 1200 onto the sterile components of the system offers asignificant advantage in usability such that when the mating processbetween the sterile and unsterile components occurs, any necessaryengagement procedure between the two components manifesting as anelectrical, mechanical, optical process, etc. can occur in parallel withthe deployment of the sterile bag 1200 over the unsterile components(e.g., PIU 1130 and cable bundle 1106). With the expectation that theengagement procedure may take several seconds, preloading the sterilebag on the sterile component eliminates any additional time that wouldbe needed to deploy a non-preloaded bag over the unsterile componentsfollowed by the time needed for mating and engagement of the sterile andunsterile components.

FIG. 4A shows a pre-deployment state where the sterile bag 1200 ispreloaded at the proximal end of the catheter handle 1122. The generalpre-deployment configuration, shown in FIG. 4A, is characterized by thesterile bag 1200 consisting of a rigid or semi-rigid component (barriersection 1210) having a circular surface containing a through-hole 1211allowing for the junction element (connecting portion 1152) of thesterile component (catheter handle 1122) responsible for mating with theunsterile component (PIU 1130) to pass through. The rigid or semirigidcomponent (barrier section 1210) is connected to the flexible bodysection 1202 composing the majority of the surface area of the sterilebag 1200 that is pleated or folded in such a way that, the flexiblebody's surface 1202 a that will contact the unsterile component'ssurface when deployed, is facing outward when predeployed, while theoutward sterile surface 1202 b faces inward, maintaining its sterilityduring predeployment. The semirigidity of the barrier section 1210interfacing with the sterile component's junction element (connectingportion 1152) allows for compression of the barrier section 1210 priorto removing the sterile component and preloaded bag from its packagingwhile still maintaining the integrity of the sterile bag-junctionelement connection during predeployment and deployment. The flexiblebody section 1202 of the sterile bag 1200 can be rolled or pleated orcreased or folded with the interior surface 1202 a facing outward priorto deployment (see FIG. 3C) in order to minimize the probability ofcontact between the exterior surface 1202 b, which requires maintenanceof sterility, and other unsterile surfaces.

FIG. 4B shows a deployed state of the sterile bag 1200. The preloadedand predeployed sterile bag 1200 can be situated on the junction element(1152) of the sterile component (1122). This is recommended in order tofacilitate minimum interference with the sterile component's operationfollowing deployment of the sterile bag 1200 over the unsterilecomponent 1130. Specifically, to ease deployment over the unsterilecomponent, and to secure the sterile barrier's semirigid componentbetween the unsterile and sterile components following mating andengagement, it is advantageous to have the sterile bag 1200 preloaded onthe junction element (1152) of the sterile component (1122).

In the event that the sterility of the sterile bag 1200 becomescompromised, e.g., where the bag 1200 may lose its sterility via contactwith an unsterile surface following deployment, or the flexible bodysection 1202 may be punctured, cut, etc., it is proposed that thesterile bag 1200 disclosed herein can be easily removed and replaced, oronly replaced. This process can occur before or after the sterile andunsterile components are mated. In the case of removing and replacingthe sterile bag prior to components mating and bag deployment, removingthe folded/pleated sterile barrier from the junction element (1152)simply involves disengaging the mechanism temporarily attaching it tothe element, such as one of those shown in FIG. 3C, and attaching a newfolded/pleated sterile barrier using the same mechanism. In the case ofreplacing the sterile barrier after mating and engagement have takenplace, the barrier may be removed via one of the previously mentionedjunction element mechanisms before or after deployment without needingto remove the sterile component, and a new folded/pleated sterilebarrier may be brought over the sterile component and attached via thesame mechanism. Additionally, if the integrity of the barrier to bereplaced permits, a new barrier or sterile bag 1200 can simply beaffixed and deployed over the previous one without removing the otherbarrier. This mechanism allows for replacement of the barrier or bag1200 without removing or replacing the sterile component, thus offeringa significant time and cost advantage over having the barrierpermanently affixed.

In the case of a compromised sterile component, where the engagementmechanism may fail, or the sterility of the sterile component iscompromised, etc., if the sterile barrier or bag 1200 has already beendeployed over the unsterile component, the bag or barrier may be leftdeployed, removed from the sterile component, and affixed to a newsterile component followed by the new sterile component's mating andengagement with the unsterile component. This mechanism allows forreplacement of the sterile component without replacing the sterilebarrier or bag 1200 already deployed over unsterile components, offeringa significant time advantage over having the barrier permanently affixedand needing to redeploy the barrier should the sterile component need tobe replaced.

The manner in which the sterile bag 1200 is preloaded onto the catheterhandle 1122 is not limited to the usage of a rigid or semirigid barriersection 1210, as described above. The present disclosure also makes useof several other configurations for affixing the rigid or semirigidbarrier section 1210 to the junction element (1152) of the catheterhandle. The primary configuration can be characterized by the semi-rigidbarrier component (barrier section 1210) previously described above witha through-hole 1211 with a diameter D₁ slightly smaller than that of thejunction element (1152). This allows for holding the barrier section1210 in place with the elastic force of the barrier component andfriction. However other structures and configurations can be used forthe barrier section 1210, as shown in FIGS. 5A-5F.

FIG. 5A shows the embodiment of the barrier section 1210, as a separatebarrier component made of semi-rigid material having a through hole witha diameter D₁, as described above in reference to FIG. 3A. FIG. 5B showsanother embodiment of a barrier section 1210, as a barrier componentmade of a rigid material (higher rigidity than the barrier component ofFIG. 5A). The barrier component of FIG. 5B includes a plurality ofperforations “p”, which serves to provide some flexibility or elasticityto the rigid material. In FIG. 5B, the barrier section 1210 has an inneropening or through-hole 1211 with a diameter marginally smaller thanthat of the junction element (1152), but with higher rigidity on theside, allowing for higher resistance during preloading and easiertranslation of the flexible body section in the direction of deployment.

FIG. 5C illustrates a further embodiment of the barrier section 1210with a ‘flower ring’ concept, relying on a ring with a diameter D₁smaller than that of the junction element (1152), but with 3 branches1213 with radii larger than that of the junction element. FIG. 5Dillustrates a ‘flower ring’ concept, relying on a ring with a diameterD₁ smaller than that of the junction element (1152), but with 4 branches1213 with radii larger than that of the junction element. In FIGS. 5Cand 5D, the barrier section 1210 has a through-hole with diametersmaller than the junction element (1152), but the material has higherrigidity. In this case, the plurality of branches of the flower ring areflexible, allowing for easier translation in the direction of preloadingthe bag (see FIG. 3C) and more difficult translation in the direction ofbag deployment (see FIG. 4B) over the unsterilized component.

FIGS. 5E and 5F illustrate a further embodiment of a barrier section1210, shown as a rigid barrier component with trough hole or centralopening 1211 having circular cutouts (cut sectors) which are configuredto engage with sector protrusions or keys 1153 of the junction element(connecting portion 1152) of the sterile component. These circularcutouts (or cut sectors) around the through hole 1211 function as alocking mechanism 1215. The barrier component 1210 shown in FIGS. 5E and5F are configured to be paired with junction element (1152) having keys1153 (shown in FIGS. 6A and 6B). In this embodiment, the rigid barriercomponent 1210 is first aligned with the keys 1153 so at to match thecut sectors 1215 with the keys 1153, and then rotated in direction R soas to not match the cut sectors with the orientation of the keys 1153 onthe junction element (1152), to thereby lock the sterile bag (attachedto the barrier component) into place.

The barrier component 1210 can be made of a rigid polymer, such asnylon, punched from a thin semirigid Mylar sheet, or even a piece ofsterilized cardboard, etc. Alternatively, it may be just a hole punchedin a closed proximal end of a tubular body coupled around it by glue toa rigid flange integral to the catheter handle. In the latter case, theflange could be removed with the handle, but the tubular body may stayover the PIU if needed. For example, in one embodiment, the simplestimplementation of the sterile bag or cover may be just a long plasticbag with a hole punched in the bottom of the bag through which aconnection between PIU and the catheter handle is made. The hole punchedin the bag may be reinforced with a piece or rigid or semirigid materialto form the barrier component, as described above, and this bag may beattached to the catheter handle flange with a temporary glue and removedif needed. In other embodiment, the plastic bag having the hole punchedin the bottom thereof can be attached directly to the flange 1122 a ofthe catheter handle 1122. In this case the barrier component 1210 has nophysical outer edge as it is just the bottom portion of the tubular bagglued to the flange 1122 a.

According to the present disclosure, with the sterile bag 1200 beingpreloaded to the catheter handle 1122 (sterile component), where theunsterile surface of the flexible body of the bag facing outward priorto deployment and allowing for drape deployment to occur simultaneouslywith mating of the unsterile and sterile components of the device,reducing time need to fully ready the device for use is achieved.Furthermore, in the event that the sterility of the exterior surface ofthe sterile bag becomes compromised, the method for affixing the barriercomponent to the sterile component allows for quick removal andreplacement of the sterile bag or deployment of another sterile bag overthe already deployed sterile bag without requiring removal of thesterile component already connected to the non-sterile component(s).This advantageously reduces the time and cost associated with replacinga damage sterile bag or requiring replacement of the sterile components.Additionally, the sterile component of the device may be replacedwithout requiring replacement of the sterile barrier and the barrier, ifalready deployed over the unsterile components of the device, may remaindeployed while the sterile component is replaced, again reducing thetime and burden that would be required to remove and redeploy a sterilebag if it were permanently affixed to the sterile component.

Another advantage is the provision of attaching tabs at the distal endof the sterile bag allowing for ease of deployment by an unsterile userwithout compromising the sterility of the sterile bag but also providingfor a method of affixing the sterile barrier to a surface so as to avoidcontact between the exterior sterile surface and an unsterile surfaceprior to bringing the barrier into the sterile field. In this regard,although a description has been made of an attaching component beingattachable tabs having a thru-hole to engage with hooks, the attachmentcomponent is not limited to tabs and corresponding hooks. Any otherattachment structure (e.g., adhesives such as Velcro®) can be used toattach the distal end of the sterile bag 1200 to an unsterile surface(e.g., the surface of the computer cart 1102). The attaching componentmay include other attaching structures, e.g., fasteners, a clasp,buttons, a zipper or any other suitable mechanism, which can be attachedand removed in any suitable manner.

The materials for the sterile cover would be selected to provideadequate barrier to prevent through contamination. As such, thin filmsof non-woven polymers (e.g. polyethylene, polyvinylchloride,polyurethane, polystyrene, polycarbonate, acrylics, silicone rubber,polypropylene, synthetic rubbers, etc.), preferably transparent for easeof use, are commonly employed. In addition, the materials selectedshould withstand sterilization method(s) selected to be used for thesterile component. For example, for a sterile component containingplastic and requiring Ethylene Oxide (EtO) sterilization method, a 2mils thick polyethylene film with 10 mils thick Mylar semi-rigid barriercomponent can be used.

Embodiment(s) of the present disclosure can be modified and/or combinedwith each other. Moreover, it is understood that numerous modificationsmay be made without departing from the scope of the disclosedembodiments.

In the present disclosure, preloading the sterile barrier to the sterilecomponent of a medical equipment system offers a significant advantagein usability such that when the mating process between the sterile andunsterile components occurs, any necessary engagement procedure betweenthe two components manifesting as an electrical, mechanical, or opticalprocess, etc., can occur in parallel with the deployment of the sterilebarrier over the unsterile component. With the projection that theengagement procedure may take several seconds, preloading the barrieronto the sterile component eliminates any additional time that would beneeded to deploy a non-preloaded barrier over the unsterile componentfollowed by the time needed for mating and engagement of the sterile andunsterile components. The general pre-deployment configuration, shown inFIG. 4A, is characterized by the sterile barrier comprising of a barriercomponent in the shape of semirigid circular surface containing athrough-hole (central opening) allowing for the junction element(connection portion 1152) of the sterile component (catheter handle1122) responsible for mating with the unsterile component to passthrough. The said semirigid barrier component section 1210 connected tothe flexible body section 1202 composing the majority of the surfacearea of the sterile barrier or bag 1200 that is pleated or folded insuch a way that, the flexible body's surface 1202 a that will contactthe unsterile component's surface when deployed, is facing outward whenpredeployed, while the outward sterile surface 1202 b of the flexiblebody faces inward, thereby maintaining its sterility duringpredeployment. The semirigidity of the barrier component interfaces withthe sterile component's junction element (1152), and allows forcompression of the flexible body against the barrier component prior toremoving the sterile component and preloaded barrier from its packagingwhile still maintaining the integrity of the sterile barrier-junctionelement connection during predeployment and deployment. The barrier canbe rolled/pleated with the interior surface facing outward prior todeployment in order to minimize the probability of contact between theexterior surface, which requires maintenance of sterility, and otherunsterile surfaces. The predeployed barrier can be situated on thejunction element of the sterile component in order to facilitate minimuminterference with the sterile component's operation followingdeployment, ease of deployment over the unsterile component, and tosecure the sterile barrier's semirigid component between the unsterileand sterile components following mating and engagement.

According to another embodiment, the sterile bag 1200 is not preloadedonto the sterile component, but it can be deployed directly onto anon-sterile component in parallel with (or immediately before) theengagement of a sterile component to an unsterile component alreadycovered by the sterile barrier, drape or bag 1200. FIG. 7A, FIG. 7B, andFIG. 7C show details of an exemplary sterile cover, drape, or bag 1200.FIG. 7A shows a perspective view of the sterile cover, drape, or bag1200 in a preloaded and pre-deployment state. The sterile bag 1200 has atubular flexible body section 1202, a barrier section 1210, and anattaching section 1220. In its preloaded state, at least part of thenon-sterile inner surface 1202 a of bag 1200 is exposed outwards.According to the embodiment shown in FIGS. 7A-7C, in the preloadedstate, the flexible body section 1202 is rolled or creased or folded orpleated (see detail A) to remain compact prior to deployment. FIG. 7Bshows detail A of FIG. 7A as one example of the manner in which the bag1200 is folded prior to loading and deployment of the bag. Specifically,prior to deployment, the sealed end (barrier section side) and the openend (attaching section side) are at substantially at the same plane, andthe body section 1202 is folded with a plurality of z-folds to form acompact package. FIG. 7C shows the deployed state of the sterile bag1200. To facilitate ease of deployment by a non-sterile user, one ormore tabs 1221 are provided around the open end of the body section1202. The tabs 1221 are attached to the un-sterile inner surface 1202 awith an adhesive 1227 (e.g., medical device adhesive or curablematerial).

In the embodiment shown in FIGS. 7A-7C, the barrier section 1210 has anopening 1211 and an adhesive-backed, semi-rigid ring (see FIG. 3A) meantto provide a means to temporarily affix the bag 1200 to the edge ordistal end of the PIU 1130 (see FIGS. 1-2) prior to deployment.Naturally, the adhesive-backed, semi-rigid ring of barrier section 1210can also provide a means to preload and temporarily affix the bag 1200to the proximal end of the catheter handle 1122 prior to deployment, asdescribed in the previous embodiments. The drape or bag 1200 is pleatedin a z-fold manner prior to deployment, with the interior surface 1202 aof the drape facing outwards pre-deployment. Pull tabs 1221 withoptional holes 1222 are affixed to the pleated interior surface 1202 aof the drape proximal to the semi-rigid ring prior to drape deployment.The tabs 1221 are used for pulling and deploying the bag by placing thebag over the most distal unsterile component, principally the PIU 1130,adhering the interior of the ring to the catheter handle or the edge ofthe PIU and aligning the opening 1211 around the catheter insertionpoint, and then unfolding the drape toward the proximal end of the PIUby pulling the pull tabs 1221 in the direction of deployment (see FIG.7C). Similar to previous embodiments, the diameter D₁ of opening 1211 isapproximately equal to the diameter “d” of the connection portion 1152or the sterile component (catheter handle 1122). When fully deployed,the drape or bag 1200 will completely contain the unsterile componentsof the PIU that pass into the unsterile field and its position will bemaintained and not obscure the catheter insertion point on the catheterhandle or PIU via the adhesion offered by the semi-rigid ring adhesiveor the lock provided by the PIU/catheter handle junction. In addition,to secure the attachment of the deployed sterile barrier or bag 1200over the unsterile components, the tabs 1221 can be tied, affixed,attached, or otherwise secured to the proximal end of the PIU or to somestructure of the console 1110.

In the embodiment of FIGS. 7A-7C, similar to the embodiment of FIGS.4A-4B, in the event that the sterility of the sterile bag 1200 becomescompromised, e.g., where the bag 1200 may lose its sterility via contactwith an unsterile surface following deployment, or the flexible bodysection 1202 may be punctured, cut, etc., the sterile bag 1200 can beeasily removed and replaced, or only replaced, before or after thesterile and unsterile components are mated. In the case of removing andreplacing the sterile bag 1200 prior to components mating, removing thefolded/pleated sterile bag 1200 from the distal end of the PIU involvesdetaching the adhesive backed semi-rigid ring 1210 from the catheterhandle or the PIU, and attaching a new folded/pleated sterile bag 1200using the same mechanism. In the case of replacing the compromisedsterile barrier after mating and engagement of sterile and unsterilecomponents have taken place, the compromised sterile bag 1200 may beleft in place, and a new folded/pleated sterile barrier may be broughtover and attached via the same procedure. That is, if the integrity ofthe new sterile barrier or bag 1200 can be maintained, such new barrieror sterile bag 1200 can simply be affixed and deployed over the previousone without removing the other compromised barrier. This mechanismallows for replacement of the barrier or bag 1200 without removing orreplacing the sterile component, thus offering a significant time savingadvantage over having the barrier permanently affixed.

An advantage of the sterile barrier disclosed herein is that it provideswith the sterile barrier being preloaded to a sterile component by usingthe rigid or semirigid barrier component. In this manner, the unsterilesurface of the barrier can be preloaded facing outward prior to barrierdeployment, and during barrier deployment allowing for barrierdeployment to simultaneously occur with mating of the unsterile andsterile components of the device, reducing time need to fully ready thedevice for use. Furthermore, the method for affixing the barrier to thesterile component allows for removal and replacement of the sterilebarrier or deployment of another barrier over the barrier already inplace without requiring removal of the sterile component of the deviceshould the sterility of exterior surface of the barrier becomecompromised, reducing the time and cost associated with replacing thebarrier requiring replacement of the sterile components. Additionally,the sterile component of the device may be replaced without requiringreplacement of the sterile barrier and the barrier, if already deployedover the unsterile components of the device, may remain deployed whilethe sterile component is replaced, again reducing the time burden thatwould be required to remove and redeploy a sterile barrier if it werepermanently affixed to the sterile component.

An additional advantage of providing tabs 1221 at the distal end of thesterile barrier or bag 1200 is that it allows for ease of deployment ofthe sterile barrier by an unsterile user without compromising barriersterility but also providing for a method of affixing the barrier to asurface so as to avoid contact between the exterior sterile surface 1202b and an unsterile component prior to bringing the barrier or bag 1200into the sterile field.

Definitions

In referring to the description, specific details are set forth in orderto provide a thorough understanding of the examples disclosed. In otherinstances, well-known methods, procedures, components and circuits havenot been described in detail as not to unnecessarily lengthen thepresent disclosure. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe subject specification, but rather only by the plain meaning of theclaim terms employed. As used herein, the term “sterile” refers to itscommon medical definition meaning totally clean and substantially freefrom bacteria or other living microorganisms. Similarly the termsunsterile and non-sterile are interchangeably used to mean not free ofliving organisms and microorganisms, as in an unsterile medicalinstrument or a medical operation done in a non-sterile environment.

It should be understood that if an element or part is referred herein asbeing “on”, “against”, “connected to”, or “coupled to” another elementor part, then it can be directly on, against, connected or coupled tothe other element or part, or intervening elements or parts may bepresent. In contrast, if an element is referred to as being “directlyon”, “directly connected to”, or “directly coupled to” another elementor part, then there are no intervening elements or parts present. Whenused, term “and/or”, may be abbreviated as “/”, and it includes any andall combinations of one or more of the associated listed items, if soprovided.

Spatially relative terms, such as “under” “beneath”, “below”, “lower”,“above”, “upper”, “proximal”, “distal”, and the like, may be used hereinfor ease of description to describe one element or feature'srelationship to another element(s) or feature(s) as illustrated in thevarious figures. It should be understood, however, that the spatiallyrelative terms are intended to encompass different orientations of thedevice in use or operation in addition to the orientation depicted inthe figures. For example, if the device in the figures is turned over,elements described as “below” or “beneath” other elements or featureswould then be oriented “above” the other elements or features. Thus, arelative spatial term such as “below” can encompass both an orientationof above and below. The device may be otherwise oriented (rotated 90degrees or at other orientations) and the spatially relative descriptorsused herein are to be interpreted accordingly. Similarly, the relativespatial terms “proximal” and “distal” may also be interchangeable, whereapplicable.

The term “about” or “approximately” as used herein means, for example,within 10%, within 5%, or less. In some embodiments, the term “about”may mean within measurement error. In this regard, where described orclaimed, all numbers may be read as if prefaced by the word “about” or“approximately,” even if the term does not expressly appear. The phrase“about” or “approximately” may be used when describing magnitude and/orposition to indicate that the value and/or position described is withina reasonable expected range of values and/or positions. For example, anumeric value may have a value that is +/−0.1% of the stated value (orrange of values), +/−1% of the stated value (or range of values), +/−2%of the stated value (or range of values), +/−5% of the stated value (orrange of values), +/−10% of the stated value (or range of values), etc.Any numerical range, if recited herein, is intended to include allsub-ranges subsumed therein.

The terms first, second, third, etc. may be used herein to describevarious elements, components, regions, parts and/or sections. It shouldbe understood that these elements, components, regions, parts and/orsections should not be limited by these terms. These terms have beenused only to distinguish one element, component, region, part, orsection from another region, part, or section. Thus, a first element,component, region, part, or section discussed below could be termed asecond element, component, region, part, or section without departingfrom the teachings herein.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a”, “an”, “said” and “the”, are intended to include theplural forms as well, unless the context clearly indicates otherwise. Itshould be further understood that the terms “includes” and/or“including”, when used in the present specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof not explicitly stated. It is furthernoted that some claims may be drafted to exclude any optional element;such claims may use exclusive terminology as “solely,” “only” and thelike in connection with the recitation of claim elements, or it may useof a “negative” limitation.

In describing example embodiments illustrated in the drawings, specificterminology is employed for the sake of clarity. However, the disclosureof this patent specification is not intended to be limited to thespecific terminology so selected and it is to be understood that eachspecific element includes all technical equivalents that operate in asimilar manner.

While the present disclosure has been described with reference toexemplary embodiments, it is to be understood that the presentdisclosure is not limited to the disclosed exemplary embodiments. Thescope of the following claims is to be accorded the broadestinterpretation so as to encompass all such modifications and equivalentstructures and functions.

What is claimed is:
 1. A sterile cover for covering medical equipment,comprising: a barrier section having a central opening; and a flexiblebody section coupled to the barrier section, the flexible body sectionextending from a proximal end to a distal end thereof, and having anouter surface, an inner surface, and an open end, wherein the barriersection is coupled to the flexible body section at the proximal endthereof and the barrier section is configured to preload the sterilecover to a sterile component or to attach the sterile cover to anunsterile component of the medical equipment, wherein the flexible bodysection is configured to be deployed over the unsterile component so asto enclose within the inner surface thereof the unsterile component, andwherein the unsterile component is connectable to the sterile componentthrough the central opening of the barrier section.
 2. The sterile coveraccording to claim 1, wherein the sterile cover is configured to bepreloaded to the sterile component, and wherein the sterile cover ispreloaded by sliding the central opening of the barrier section onto aconnecting portion of the sterile component that mates with theunsterile component.
 3. The sterile cover according to claim 1, whereinthe sterile cover is configured to be temporarily affixed to theunsterile component in a pleated or folded state such that the sterilecover can be removed from the unsterile component and replaced with adifferent sterile cover at any time before or after deployment, or atany time before or after engagement of the sterile and unsterilecomponents.
 4. The sterile cover according to claim 1, wherein thesterile cover is a first sterile cover configured to be temporarilyaffixed to the sterile component or the unsterile component in a pleatedor folded state such that the first sterile cover can be enclosed with asecond sterile cover at any time after deployment of the first sterilecover.
 5. The sterile cover according to claim 1, wherein the barriersection is configured to be temporarily affixed to a connecting portionof the sterile component that mates with the unsterile component, suchthat the barrier section can be removed and replaced withoutnecessitating removal of the flexible body section following deploymentof the sterile cover.
 6. The sterile cover according to claim 1, furthercomprising: an attaching section provided at the distal end of theflexible body section, the attaching section configured to provide aninterface for an unsterile user to deploy the sterile cover over theunsterile component without coming into contact with sterile surfaces,and for securing the distal end of the flexible body section followingdeployment, thereby preventing contact with unsterile surfaces.
 7. Thesterile cover according to claim 6, wherein the attaching sectionincludes one or more tabs arranged at the distal end of the flexiblebody section around the open end thereof, and wherein the one or moretabs are configured to be attached to an unsterile surface of themedical equipment.
 8. The sterile cover according to claim 1, whereinthe barrier section is a rigid or semirigid component having a throughhole configured to tightly fit over a connecting portion of the sterilecomponent.
 9. The sterile cover according to claim 8, wherein thebarrier section includes a plurality of perforations surroundingradially the through hole.
 10. The sterile cover according to claim 8,wherein the through hole is the central opening having a diametersmaller than a diameter of a junction element of the sterile component,and wherein the barrier section includes a plurality of flexiblebranches surrounding radially the through hole.
 11. The sterile coveraccording to claim 8, wherein the through hole is the central openinghaving a diameter substantially equal to a diameter of a junctionelement of the sterile component, and wherein the barrier sectionincludes one or more circular cutouts or sectors which function as alocking mechanism configured to engage with one or more keys formed inthe junction element of the sterile component.
 12. The sterile coveraccording to claim 1, wherein the barrier section is an adhesive-backedrigid or semirigid component having a through hole, wherein theadhesive-backed rigid or semirigid component is configured to betemporarily attached to a distal end of the unsterile component, andwherein the through hole aligned with a connecting portion of thesterile component.
 13. The sterile cover according to claim 1, whereinthe flexible body section is a long tubular plastic bag with a hole inthe bottom of the plastic bag, and the hole in the bottom of the plasticbag is the central opening of the barrier section, and wherein thesterile component is connected to the unsterile component through thehole in the bottom of the plastic bag.
 14. The sterile cover accordingto claim 1, wherein the flexible body section has a tubular shapeconfigured to fit over the unsterile component.
 15. The sterile coveraccording to claim 6, wherein the attaching section includes a ringshaped structure arranged at the distal end of the flexible body sectionaround the open end thereof, and wherein the ring shaped structure hasone or more holes configured to be engaged to an unsterile surface ofthe medical equipment.
 16. A sterile barrier/drape configured to bepreloaded to a sterile component or an unsterile component which are tobe mated or engaged to each other, the sterile barrier comprising: abarrier component having a central opening; and a flexible body coupledto the barrier component, the flexible body having a hollow passageextending from a proximal end to a distal end thereof, and having anouter surface, an inner surface, and an open end, wherein the barriercomponent is coupled to the flexible body at the proximal end thereofand the central opening of the barrier component is configured to couplethe sterile barrier/drape to the sterile component or the unsterilecomponent; and wherein the flexible body is configured to enclose withinthe inner surface thereof the unsterile component removably connected tothe sterile component through the central opening of the barriercomponent.
 17. The sterile barrier/drape according to claim 16, whereinthe sterile barrier/drape is a first sterile barrier/drape configured tobe temporarily affixed to a sterile component, and configured to beremoved from the sterile component and replaced or just replaced with asecond sterile barrier/drape at any point before or after barrierdeployment and sterile and unsterile components mating.
 18. The sterilebarrier/drape according to claim 16, wherein the sterile barrier/drapeis configured such that a sterile component can be removed and replacedwithout necessitating removal of the sterile barrier/drape followingbarrier/drape deployment.
 19. The sterile barrier/drape according toclaim 16, wherein the sterile barrier/drape has a tubular opening havingthe proximal and distal ends, and further comprising: a fixture on thedistal end of the sterile barrier/drape for use in providing aninterface for an unsterile user to deploy the sterile barrier/drapewithout coming into contact with sterile surfaces and securing thedistal end of the sterile barrier/drape following deployment, preventingcontact with unsterile surfaces.
 20. A method of providing a sterilebarrier/drape preloaded to a sterile component or attachable to anunsterile component of medical equipment, the method comprising:providing the sterile barrier/drape with a barrier section and aflexible body section coupled to the barrier section; the barriersection having a central opening, and the flexible body section having atubular shape extending from a proximal end to a distal end thereof, andhaving an outer surface, an inner surface, and an open end; preloadingthe barrier section onto the sterile component by sliding the centralopening of the barrier section onto a connecting portion of the sterilecomponent or preloading the barrier section onto the unsterile componentby attaching the barrier section onto a distal end of the unsterilecomponent which is aligned the connecting portion of the sterilecomponent; and deploying the flexible body section over the unsterilecomponent so as to enclose within the inner surface of the flexible bodysection the unsterile component in parallel with connecting the sterilecomponent to the unsterile component through the central opening of thebarrier section.
 21. The method according to claim 19, furthercomprising: after deployment of the flexible body section over theunsterile component, removing and replacing or only replacing thebarrier section without removing the flexible body section.
 22. Themethod according to claim 19, further comprising: after deployment ofthe flexible body section over the unsterile component, removing andreplacing or only replacing the barrier section and/or the flexible bodysection without disconnecting the sterile component from the unsterilecomponent.